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1. (WO2000074554) CARTILAGE REPAIR UNIT
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WE CLAIM:
1. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of a delivery unit and a porous insert;
(A) said delivery unit being formed of bio-absorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover; and
(B) said insert being supported by said delivery unit, formed of bio-absorbable material, and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.
2. The system of Claim 1 wherein said insert is disposed on the upper, lower and outer surfaces of said support arms.
3. The system of Claim 1 wherein said support arms have free ends circumferentially spaced from one another to define areas for receipt of a chondrogenic growth-supporting matrix.
4. The system of Claim 1 wherein said support arms have circumferentially spaced free ends adapted to engage and at least partially spatially stabilize said insert.
5. The system of Claim 1 wherein said support arm free ends are horizontally barbed.

6. The system of Claim 1 wherein said support arm free ends are vertically barbed.
7. The system of Claim 1 wherein said insert has a top, a bottom and a sidewall connecting said top and bottom, said bottom allowing vascular invasion therethrough, and said top and sidewall allowing cellular migration therethrough by an adjacent healthy area of articular cartilage and subchondral cancellous bone.
8. The system of Claim 7 wherein said sidewall is polygonal in plan.
9. The system of Claim 1 wherein each of said delivery unit and said insert essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.
10. The system of Claim 1 additionally including retainer means securing said insert to said delivery unit.
11. The system of Claim 10 wherein said retainer means is secured to a portion of said central body below said insert and bears upwardly against said insert.
12. The system of Claim 10 wherein said retainer means essentially consists of completely bio-absorbable material which is
dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.
13. The system of Claim 1 additionally including a porous film formed of bio-absorbable material securing said insert to said delivery unit.
14. The system of Claim 13 wherein said porous film has a central film portion disposed over said insert and a plurality of film fingers projecting outwardly from said central film portion, downwardly and inwardly, under said support arms.

15. The system of Claim 14 additionally including retainer means secured to a lower part of said central body and bearing upwardly against said film fingers.
16. The system of Claim 13 wherein said porous film essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.
17. The system of Claim 1 wherein said central body adjacent a bottom end thereof defines a plurality of outwardly extending flanges.
18. The system of Claim 1 wherein said insert is a flexible porous film formed of bio-absorbable material secured to said delivery unit.
19. The system of Claim 18 wherein said porous film has a central film portion disposed over said support arms and a plurality of film fingers projecting outwardly from said central film portion, downwardly and inwardly, under said support arms.
20. The system of Claim 19 additionally including retainer means secured to a lower part of said central body and bearing upwardly against said film fingers.
21. The system of Claim 18 wherein said porous film essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.
22. The system of Claim 1 wherein said central body defines an aperture extending longitudinally therethrough.
23. The system of Claim 22 wherein said insert defines an aperture extending longitudinally therethrough.

24. The system of Claim 22 additionally including retainer means secured to a lower part of said central body and bearing upwardly against said insert, said retainer body defining an aperture extending longitudinally therethrough coaxial with said central body aperture.
25. The system of Claim 22 additionally including a porous film consisting substantially of completely bio-absorbable material securing said insert to said delivery unit, said porous film defining an aperture extending longitudinally therethrough coaxial with said central body aperture.
26. The system of Claim 22 wherein said insert is a flexible porous film consisting substantially of completely bio-absorbable material secured to said delivery unit, said porous film defining an aperture extending longitudinally therethrough coaxial with said central body aperture.
27. The system of Claim 1 wherein at least a portion of said delivery unit central body disposed below said insert defines flexible legs, said system additionally including means for moving said legs from a horizontally retracted orientation enabling removal of said assembly to a horizontally expanded orientation fixing said assembly in place.
28. The system of Claim 27 wherein said flexible legs are resilient, and said moving means is retractable to enable movement of said legs from said expanded orientation to said retracted orientation.
29. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of a delivery unit and a porous insert;
(A) said delivery unit being formed of bio-absorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said delivery unit having a central body and a plurality of radially extending circumferentially spaced, support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover;
(B) said insert being supported by said delivery unit, formed of bio-absorbable material, and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;
at least a portion of said delivery unit central body disposed below said insert defining flexible legs, said system additionally including means for moving said legs from a horizontally retracted orientation enabling removal of said assembly to a horizontally expanded orientation fixing said assembly in place.
30. The system of Claim 29 wherein said flexible legs are resilient, and said moving means is retractable to enable movement of said resilient legs from said expanded orientation to said retracted orientation.
31. A cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of a delivery unit and a porous insert;
(A) said delivery unit being formed of bio-absorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said delivery unit having a central body and a plurality of radially extending circumferentially spaced, support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover;
(B) said insert being supported by said delivery unit, substantially formed of bio-absorbable material, and establishing
communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;
said insert including cartilage or cartilage-progenitor cells to facilitate establishing said communication.
32. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of a delivery unit and a porous insert;
(A) said delivery unit being formed of bio-absorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover; said delivery unit being a subassembly of two separately formed components, (i) one of said components being configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, and (ii) the other component having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover; and
(B) said insert being supported by said delivery unit, formed of bio-absorbable material, and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.
33. The system of Claim 32 wherein said subassembly includes retainer means for bearing on a portion of said insert intermediate said two components to lock said insert portion in place.
34. The system of Claim 32 wherein said subassembly is assembled with said insert prior to use.
35. The system of Claim 32 wherein said first component defines a longitudinal aperture therethrough, and said central body of said other component is configured and dimensioned to at least partially pass through said aperture.
36. The system of Claim 32 wherein at least one of said components includes means for retaining said components together after assembly.
37. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly consisting essentially of two delivery units and a single flexible porous insert;
(A) each of said delivery units being formed of bioabsorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, each said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover; and
(B) said insert being supported by both of said delivery units, formed of flexible bio-absorbable material, and establishing
communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;
said delivery units being configured and
dimensioned to enable them to be disposed along a common longitudinal axis, facing each other, and connected only by said insert for insertion into a patient and then unfolded to enable them to be separately mounted along generally parallel longitudinal axes, side-by-side.
38. The system of Claim 37 wherein said insert defines a pair of insert portions, each said insert portion extending over the top of a respective one of said delivery units, and a connecting portion of reduced width foldably connecting said insert portions together.
39. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of a delivery unit and a porous insert;
(A) said delivery unit being formed of bio-absorbable material and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, said delivery unit having a central body and an inwardly compressible plurality of spirally or helically extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert at least partially thereover; and
(B) said insert being supported by said delivery unit, formed of bio-absorbable material, and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.
40. The system of Claim 39 comprising at least two of said assemblies, each said delivery unit being mounted side-by-side such that at least one support arm of one of said delivery units inwardly compresses at least one support arm of the other of said delivery units.
41. The system of Claim 40 wherein said at least one support arm of said one delivery unit would overlap said at least one support arm of said other delivery unit if at least one support arm were not inwardly compressed.
42. The system of Claim 7 wherein said sidewall is circular in plan.
43. The system of Claim 43 wherein said insert and said support arms are deflectable.
44. The system of Claim 1 wherein a top layer of said insert contains a chondrogenic growth-supporting matrix, and a lower portion of said insert contains an osteogenic growth-supporting matrix, said assembly being configured and dimensioned to be disposed with said chondrogenic growth-supporting matrix adjacent a healthy area of articular cartilage, and said osteogenic growth-supporting matrix adjacent a healthy area of subchondral cancellous bone, thereby to establish chondrogenic and osteogenic growth- supporting matrices in removed areas of damaged or destroyed articular cartilage and subchondral bone, respectively.
45. The system of Claim 1 wherein said delivery unit includes a head portion and a stem portion, said head and stem portions being pivotally joined together.
46. The system of Claim 45 wherein one of said portions define a ball and the other of said portions defines a socket.
47. The system of Claims 46 wherein said delivery unit includes a head portion and a stem portion, said stem portion defining a ball at a distal end, and said head portion defining a socket at a proximal end, said ball being pivotally maintained in said socket such that said head portion is pivotable relative to said stem portion.